SAINT-PRIEST, France--(BUSINESS WIRE)--Regulatory News:
Biom’up (the « Company »), specializing in surgical hemostasis, today announced the appointment of George Makhoul as Chief Commercial Officer with responsibility for the United States, effective today.
Mr. Makhoul has a track record in commercializing medical products to hospitals and surgeons combined with a strong experience of the US hemostasis market. He will oversee all Biom’up sales and marketing activities in the US and work to strengthen the presence of the Company in this strategic market as the launch of its flagship product HEMOBLASTTM Bellows, a hemostatic product to control bleeding in a broad range of both traditional and laparoscopic surgical procedures, continues to gain market traction.
He joins a team of veteran sales and marketing executives overseeing a nationwide network of more than 200 representatives. He will report directly to the Group CEO, Mr. Etienne Binant.
Etienne Binant, Chief Executive Officer of Biom’up, declared: « The entire Biom’up team joins me to welcome George Makhoul as a new senior executive member. George is a proven commercial leader and a strategic thinker with cross-divisional experience in both sales and marketing roles in medical device and pharmaceutical companies. George joins us at an opportune time to accelerate the emerging commercial success of HEMOBLAST Bellows as the hemostatic product of choice for surgeons in the U.S. market. We all very much look forward to working with him. »
George Makhoul said: “I am enthusiastic about joining Biom’up. The commitment to excellence from everyone in the organization positions us for disruptive and exponential growth in the hemostasis market.”
George Makhoul has over 16 years of sales, marketing, and business development leadership experience in both the medical device and pharmaceutical industries, specifically in hemostasis as well as over 13 years of targeted focus in Biosurgery, Orthopedics, and Biologics. He has led teams on both a large and small scale ranging from $10M - $1.8B in annual revenues.
Prior to joining Biom’up, Mr. Makhoul spent eight years at Stryker in multiple senior leadership positions. While at Stryker, Mr. Makhoul successfully led the sales and marketing functions of two separate new divisions within Stryker’s Orthobiologics business unit, including leading teams that developed products from conception to commercialization. Other organizations he has served prior to Stryker are Wyeth (now Pfizer), Genzyme, and Precision Therapeutics.
George Makhoul holds a degree in Business Management from Moravian College.
Founded in 2005 and based in the Lyon suburb of Saint-Priest (France), Biom’up develops and commercializes hemostatic products based on patented biopolymers designed to simplify traditional and laparoscopic surgical procedures in numerous specialties such as cardiac, general and orthopedic, and give patients a better quality of life. The Company’s lead product, HEMOBLAST Bellows, is marketed in Europe and the United States.
Since its creation, Biom’up has benefited from the support of prominent European and US investors. The Company’s shareholders include Bpifrance (including its Innobio fund), Gimv, Lundbeckfond, Athyrium Capital and Invesco, as well as all the Company’s management team. Biom'up successfully completed its IPO on Euronext Paris, raising €42.5 million in October 2017.
Since then, the Company carried out a €16 million capital increase in February 2018 and a €7.7 million capital increase by means of a private placement in December 2018. It also entered into a €25 million bond financing agreement with Athyrium, a U.S. fund specializing in innovative companies in the healthcare sector, in March 2018, brought to €28 million in December 2018.
About HEMOBLAST Bellows
HEMOBLAST Bellows is a hemostatic product to control bleeding in a broad range of both open and laparoscopic surgical procedures, such as cardiac, general and orthopedic surgeries, and give patients a better quality of life.
Uncontrolled bleeding is a major surgical complication associated with higher mortality, longer hospitalization and higher rates of transfusions and reoperations. Beyond its impact on patient’s health, this major complication causes excess costs in all surgical specialties and is a burden for hospital budgets across the globe. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated SPOT GRADE™ Surface Bleeding Severity Scale (SBSS), which demonstrates the ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding. HEMOBLAST Bellows is proven to control bleeding with flow rates up to 117 mL per minute. Due to its efficacy, versatility and ease of use, HEMOBLAST Bellows is quickly becoming a popular choice amongst U.S. surgeons looking for new options to control surgical bleeding challenges.
Biom’up obtained CE Marking for HEMOBLAST Bellows in December 2016 and, on the basis of compelling preliminary results (93% effectiveness at 6 minutes, compared with 74% for the control arm) in the pivotal trial, expedited FDA approval for HEMOBLAST Bellows in December 2017, seven months ahead of the original plan. This allowed for the commercial roll-out of its lead product in the U.S. in summer of 2018. The Company’s successful pivotal clinical trial in the U.S. included 412 patients admitted to cardio-thoracic, abdominal or orthopedic (lower limb) surgeries and met all of its primary and secondary endpoints.
In July 2018, Biom’up additionally obtained CE Marking for its HEMOBLAST Bellows Laparoscopic Applicator designed to deliver the HEMOBLAST Bellows powder in all minimally-invasive procedures. In January, 2019, the Company obtained the respective approval for HEMOBLAST Bellows Laparoscopic Applicator in the U.S. This has opened up new market segments, representing approximately 500,000 and 443,000 surgeries per year in Europe and the U.S. respectively.
Currently the Company is working to expand the range of applications for HEMOBLAST Bellows. In addition, the approval from the Australian health authorities for the Company’s lead product is expected during the first half of 2019.